K182809 is an FDA 510(k) clearance for the CUSA Clarity Ultrasonic Surgical Aspirator System, a Instrument, Ultrasonic Surgical, submitted by Integra LifeSciences Corporation (Planisboro, US). The FDA issued a Cleared decision on December 7, 2018, 65 days after receiving the submission on October 3, 2018. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K182809 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 03, 2018 |
| Decision Date | December 07, 2018 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LFL — Instrument, Ultrasonic Surgical |
| Device Class | — |